scholarly journals A methodological survey on reporting of pilot and feasibility trials for physiotherapy interventions: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e020580
Author(s):  
Luiz Felicio Cadete Scola ◽  
Anne M Moseley ◽  
Lehana Thabane ◽  
Matheus Almeida ◽  
Lucíola da Cunha Menezes Costa
Keyword(s):  
Descriptive Analysis ◽  
Reporting Quality ◽  
Estimating Equation ◽  
Primary Analysis ◽  
Factors Associated ◽  
Ethical Approval ◽  
Evidence Database ◽  
Randomised Controlled ◽  
Full Trial ◽  
Completeness Of Reporting

IntroductionPilot and feasibility trials aim to test whether a full trial can be conducted or if any procedures must be changed for the full trial. Pilot trials must be reported in a transparent, accurate and complete way. In this report, we present a protocol for a methodological survey with the following aims: (1) to determine the percentage of physiotherapy trial reports which claim to be pilot or feasibility trials that evaluate feasibility, (2) to determine the aspect of feasibility evaluated in the primary objectives of the pilot or feasibility trials, (3) to describe the completeness of reporting of abstracts and full articles of pilot or feasibility trials using the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials and (4) to investigate factors associated with completeness of reporting of pilot or feasibility trials.Methods and analysisReports of randomised controlled trials indexed in the Physiotherapy Evidence Database (PEDro) that claim to be pilot or feasibility trials and published in 2011–2017 will be included. Two independent reviewers will confirm eligibility and classify the aspect of feasibility being evaluated in the objectives of the included pilot or feasibility trials. Completeness of reporting of both the abstract and the full article will be evaluated using the CONSORT extension to randomised pilot and feasibility trials. The primary analysis will be a descriptive analysis about the reporting quality of abstracts and full texts of pilot and feasibility trials. We will use generalised estimating equation analysis to explore factors associated with completeness of reporting.Ethics and disseminationThe results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal. Ethical approval is not necessary for this study.

scholarly journals Evaluation of capillary pathologies by nailfold capillaroscopy in patients with psoriasis vulgaris: study protocol for a prospective, controlled exploratory study

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021595 ◽  
Author(s):  
Christine Fink ◽  
Samuel Kilian ◽  
Ines Bertlich ◽  
Elti Hoxha ◽  
Felicitas Bardehle ◽  
...  
Keyword(s):  
Exploratory Study ◽  
Psoriasis Vulgaris ◽  
Morphological Changes ◽  
Descriptive Analysis ◽  
Nailfold Capillaroscopy ◽  
Increased Risk ◽  
Ethical Approval ◽  
Randomised Controlled ◽  
Nailfold Capillaries

IntroductionPsoriasis vulgaris was shown to be an independent factor increasing the risk of several comorbidities such as obesity, diabetes and dyslipidaemia with an increased risk of stroke and myocardial infarction. We hypothesise that early endothelial dysfunction, which plays a crucial role in the pathogenesis of atherosclerosis, may be detected by digital video nailfold capillaroscopy (DVNC) at the level of the dermal capillary microvasculature as a surrogate parameter. Nailfolds represent the only body site allowing for a non-invasive assessment of the capillary microvasculature at a horizontal plane. DVNC is a well-established diagnostic tool for in vivo assessment of the peripheral microcirculation by evaluating the morphology of dermal papillary capillaries. To date, reports on morphological changes of the non-lesional nailfold capillaries in patients with psoriasis vulgaris are scarce and the existing data are not conclusive.Methods and analysisThis is a prospective, single-centre, non-randomised, controlled, exploratory study assessing the capillary patterns in 100 subjects affected by psoriasis vulgaris. Non-lesional nailfold capillaries will be imaged by means of DVNC (Optilia Digital Capillaroscopy System, Optilia Instruments AB, Sollentuna, Sweden) in 50 patients affected by psoriasis vulgaris and 50 healthy controls. Assessments will include a qualitative, descriptive analysis of the nailfold capillaries’ morphology, as well as a quantitative investigation (frequency, extent) of changes in capillary patterns. Moreover, patients’ characteristics associated with the manifestation of nailfold capillaries’ pathologies including well-known cardiovascular risk markers will be studied.Ethics and disseminationEthical approval was provided by the ethic committee of the medical faculty of the University of Heidelberg (Ethics approval number S-447/2017). The design and the final results of the study will be published and made available to the public.Trial registration numberDRKS00012856.

scholarly journals Completeness of reporting of quality improvement studies in neonatology is inadequate: a systematic literature survey

2021 ◽  
Vol 10 (2) ◽  
pp. e001273
Author(s):  
Zheng Jing Hu ◽  
Gerhard Fusch ◽  
Catherine Hu ◽  
Jie Yi Wang ◽  
Zoe el Helou ◽  
...  
Keyword(s):  
Quality Improvement ◽  
Reporting Quality ◽  
Factors Associated ◽  
Funding Sources ◽  
The Mean ◽  
Number Percentage ◽  
Field Of Inquiry ◽  
Completeness Of Reporting ◽  
Number Of Authors

IntroductionQuality improvement (QI) is a growing field of inquiry in healthcare, but the reporting quality of QI studies in neonatology remains unclear. We conducted a systematic survey of the literature to assess the reporting quality of QI studies and factors associated with reporting quality.MethodsWe searched Medline for publications of QI studies from 2016 to 16 April 2020. Pairs of reviewers independently screened citations and assessed reporting quality using a 31-item modified Standards for Quality Improvement Reporting Excellence, 2nd edition (SQUIRE 2.0) checklist. We reported the number (percentage) of studies that reported each item and their corresponding 95% CIs. We used Poisson regression to explore factors associated with reporting quality, namely, journal endorsement of SQUIRE 2.0, declaration of funding sources, year of publication and number of authors. The results were reported as incidence rate ratio (IRR) and 95% CI.ResultsOf 1921 citations, 336 were eligible; among them, we randomly selected 100 articles to assess reporting quality. The mean (standard deviation) number of SQUIRE 2.0 items adhered to was 22.0 (4.5). Percentage of articles reporting each item varied from 26% to 100%. Journal endorsement of SQUIRE 2.0 (IRR=1.11, 95% CI 1.02 to 1.21, p=0.015), declaration of funding sources and increasing number of authors were significantly associated with better reporting.ConclusionsReporting quality of QI studies in neonatology is inadequate. Endorsing the SQUIRE 2.0 guideline is a step that journals can implement to enhance the completeness of reporting.

scholarly journals Using the CONSORT statement to evaluate the completeness of reporting of addiction randomised trials: a cross-sectional review

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e032024 ◽  
Author(s):  
Matthew Vassar ◽  
Sam Jellison ◽  
Hannah Wendelbo ◽  
Cole Wayant ◽  
Harrison Gray ◽  
...  
Keyword(s):  
Reporting Quality ◽  
Consort Statement ◽  
Quality Of Reporting ◽  
Cross Sectional ◽  
The Consort Statement ◽  
Pubmed Search ◽  
Randomised Controlled ◽  
Poor Reporting ◽  
Completeness Of Reporting

ObjectivesEvaluate the completeness of reporting of addiction randomised controlled trials (RCTs) using the Consolidated Standards of Reporting Trials (CONSORT) statement.SettingNot applicable.ParticipantsRCTs identified using a PubMed search of 15 addiction journals and a 5-year cross-section.Outcome measuresCompleteness of reporting.ResultsOur analysis of 394 addiction RCTs found that the mean number of CONSORT items reported was 19.2 (SD 5.2), out of a possible 31. Twelve items were reported in <50% of RCTs; similarly, 12 items were reported in >75% of RCTs. Journal endorsement of CONSORT was found to improve the number of CONSORT items reported.ConclusionsPoor reporting quality may prohibit readers from critically appraising the methodological quality of addiction trials. We recommend journal endorsement of CONSORT since our study and those previous have shown that CONSORT endorsement improves the quality of reporting.

scholarly journals Exercise and education for community-dwelling older participants with knee osteoarthritis: a video-linked programme protocol based on a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lin Wang ◽  
Suhang Xie ◽  
Tianjie Bao ◽  
Siyi Zhu ◽  
Qiu Liang ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Rating Scale ◽  
Controlled Trial ◽  
Pressure Pain Threshold ◽  
Estimating Equation ◽  
Community Dwelling ◽  
Self Report ◽  
Exercise Programmes ◽  
Randomised Controlled

Abstract Background Neuromuscular and quadriceps exercises have been shown to be effective approaches to relieve pain and to improve function for patients with knee osteoarthritis. In this study, we aim to provide an informative feasible model in which therapeutic exercise and education will be undertaken with physiotherapy supervision and instruction via video link. We also aim to explore the relationship between program-induced pain alleviation/functional improvements and reduction in irritability, which might be mediated through program-induced psychosocial benefits. Methods In this proposed two-parallel group (neuromuscular exercise versus quadriceps exercise), single-blinded, randomised controlled trial, participants aged ≥50 years with osteoarthritic knee pain will undergo a 12-week intervention, comprising video-linked education, supervised exercises, and a 12-week follow-up. Seven measurements will be taken to collect longitudinal data. A generalised estimating equation will be used to establish the adjusted difference in effectiveness on pain, function, irritability, and psychosocial outcomes between participants undertaking neuromuscular exercises and those undertaking quadriceps exercises. The primary outcomes are overall average pain in the knee joint during walking, as assessed through the 11-point Numerical Pain Rating Scale, and the Western Ontario and McMaster Universities osteoarthritis index physical function subscale. Furthermore, pressure pain threshold and changes in self-report pain scores pre-, during, and post-exercise were also measured as an indication of irritability. In addition, both the 6-min walk test and a timed up & go test were used to assess walking function performance. Finally, patients’ emotions (e.g., fear and catastrophising), self-trust, needs in terms of disease knowledge, mental resilience, social support and health-related quality of life were investigated. Two four-wave cross-lagged models will be used to investigate directional relationships, aiming to investigate the complex mechanisms concerning the effects of exercise programmes. Discussion Through summarising the study’s strengths and limitations, this study may provide promising insights in terms of exercise therapy optimisation for people with knee osteoarthritis and/or other chronic pain within a psychosocial framework. Trial registration ChiCTR2100041978 (chictr.org.cn), January 10, 2021.

scholarly journals Using video in childbirth research

2015 ◽  
Vol 24 (2) ◽  
pp. 177-189 ◽  
Author(s):  
J Davis Harte ◽  
Caroline SE Homer ◽  
Athena Sheehan ◽  
Nicky Leap ◽  
Maralyn Foureur
Keyword(s):  
Video Recording ◽  
Research Process ◽  
Ethics Committee ◽  
Ethnographic Study ◽  
Australian Health ◽  
Healthcare Settings ◽  
Video Research ◽  
Unit Design ◽  
Ethical Approval ◽  
Randomised Controlled

Background: Conducting video-research in birth settings raises challenges for ethics review boards to view birthing women and research-midwives as capable, autonomous decision-makers. Aim: This study aimed to gain an understanding of how the ethical approval process was experienced and to chronicle the perceived risks and benefits. Research design: The Birth Unit Design project was a 2012 Australian ethnographic study that used video recording to investigate the physical design features in the hospital birthing space that might influence both verbal and non-verbal communication and the experiences of childbearing women, midwives and supporters. Participants and research context: Six women, 11 midwives and 11 childbirth supporters were filmed during the women’s labours in hospital birth units and interviewed 6 weeks later. Ethical considerations: The study was approved by an Australian Health Research Ethics Committee after a protracted process of negotiation. Findings: The ethics committee was influenced by a traditional view of research as based on scientific experiments resulting in a poor understanding of video-ethnographic research, a paradigmatic view of the politics and practicalities of modern childbirth processes, a desire to protect institutions from litigation, and what we perceived as a paternalistic approach towards protecting participants, one that was at odds with our aim to facilitate situations in which women could make flexible, autonomous decisions about how they might engage with the research process. Discussion: The perceived need for protection was overly burdensome and against the wishes of the participants themselves; ultimately, this limited the capacity of the study to improve care for women and babies. Conclusion: Recommendations are offered for those involved in ethical approval processes for qualitative research in childbirth settings. The complexity of issues within childbirth settings, as in most modern healthcare settings, should be analysed using a variety of research approaches, beyond efficacy-style randomised controlled trials, to expand and improve practice-based results.

scholarly journals Saúde Oral - Fatores de Não Adesão aos Cheques-Dentista: Um Estudo de Caso-Controlo

2018 ◽  
Vol 31 (6) ◽  
pp. 303
Author(s):  
Rita Filipe ◽  
Pedro Aguiar
Keyword(s):  
Case Control Study ◽  
Descriptive Analysis ◽  
Community Health Center ◽  
Multivariate Statistical ◽  
Expiry Date ◽  
Factors Associated ◽  
School Year ◽  
State Schools ◽  
Control Study ◽  
Main Factor

Introduction: A dental voucher was created to facilitate the access to oral health care, however the use of these vouchers, by students aged 7, 10 and 13 with dental caries from state schools within the geodemographic area covered by the Community Health Center Group of Western Lisbon and Oeiras, had a low uptake (23%, school year 2014/2015) The aim of this study was to examine the factors associated with this non-use.Material and Methods: A case-control study was carried out involving 270 students (135 cases and 135 controls) from 35 state schools who agreed to participate in the study. A descriptive analysis of the reasons for non-adhesion to the voucher, and a study associating the variables and the use/non-use of the dental vouchers using bivariate and multivariate statistical analysis was made adopting a significance of 0.05.Results: The main reasons for non-use (n = 135) were the use of private dentists outside the dental voucher scheme (23.7%) and forgetting to use the vouchers or exceeding the expiry date (21.5%). The main factor associated with the non-use was students having a private dentist (OR adjusted 2.004, p = 0.012; IC 95%: 1.176 – 3.413) and the main factor associated with the use was having information of dentists accepting dental vouchers (OR adjusted 0.096, p = < 0.001; IC 95%: 0.047 – 0.198).Discussion: Our findings highlight the need to improve the accessibility to dental vouchers.Conclusion: It is hoped that the identification of these factors will contribute in the planning of strategies and activities to improve the use of dental vouchers.

scholarly journals Profilaxia Pré-Exposição para o Vírus da Imunodeficiência Humana no Currículo Médico em Portugal: Uma Análise Transversal

2022 ◽  
Vol 35 (13) ◽  
Author(s):  
Francisco Duarte ◽  
Nuno Rua ◽  
David Gomes ◽  
Vasco Ricoca Peixoto ◽  
Daniela Azevedo ◽  
...  
Keyword(s):  
Medical Students ◽  
Online Survey ◽  
Descriptive Analysis ◽  
Medical Schools ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Factors Associated ◽  
School Year ◽  
Exposure Prophylaxis

Introduction: Pre-exposure prophylaxis (PrEP) has gained relevance as a method of prevention for HIV in certain people and settings. Following the publication of the guideline on PrEP prescribing in Portugal, we aimed to assess the knowledge of Portuguese Medical Students about PrEP.Material and Methods: An online survey was sent to Medical students of Portuguese Medical Schools. We conducted a descriptive analysis of the results and an analytic cross-sectional study to identify factors associated with “knowing about PrEP”, “having had one class about PrEP” and “identifying eligible groups correctly”.Results: Of the 796 students that responded to the survey, 64.6% were aware of what PrEP is. Of these, 34.44% acquired this knowledge during their training. Out of the total amount of respondents, 4.77% could identify correctly and completely the eligible groups for PrEP. As the training years went by, the probability of being aware of PrEP, having had one class about PrEP, and identifying the eligible groups correctly, increased. Of the sixth-year students, 43.48% had had one class about PrEP and among the students that were aware of PrEP, 28% identified what the eligible groups were. After adjusting for the school year, we found differences between Medical Schools regarding the outcomes. The association between the different ways of learning about PrEP and the ability to correctly identify eligible groups for PrEP was not statistically significant.Conclusion: The differences between Medical Schools could be harmonized through changes in the medical curricula that would allow this topic to be addressed more often.

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